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The Dosimetry, Safety and Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer

NCT07468708 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-29

No results posted yet for this study

Summary

This goal of this study is to investigate the dosimetry, safety, biodistribution of ⁶⁸Ga-FC516. In this study, we will evaluate the safety, biodistribution and dosimetry of ⁶⁸Ga-FC516 in subjects and compared them with the results of ⁶⁸Ga-labeled prostate cancer-targeting tracer imaging to evaluate the dosimetric characteristics and diagnostic efficacy of ⁶⁸Ga-FC516.

Conditions

Interventions

DRUG

⁶⁸Ga-FC516

Healthy subjects will receive ⁶⁸Ga-FC516 injection followed by PET/CT scans at multiple timepoints post-administration.

DRUG

⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer

Patients with prostate cancer will undergo both ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer PET/CT scans with a minimum interval of 24 hours and a maximum of 14 days between the two.

Sponsors & Collaborators

  • First Affiliated Hospital of Jinan University

    collaborator OTHER

  • FindCure Biosciences (ZhongShan) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-09
Primary Completion
2026-07-31
Completion
2026-08-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07468708 on ClinicalTrials.gov